SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced that the FDA’s Office of Orphan Products Development has granted Orphan Drug Designation (ODD) for SuppreMol’s lead product SM101, a recombinant human soluble Fcγ receptor IIb, for the treatment of Idiopathic Thrombocytopenic Purpura (ITP).
At present, SM101 is in a Phase Ib/IIa clinical study in ITP, with results expected in early 2011. For the same indication, the molecule has already been granted Orphan Medicinal Product Designation in Europe by the EU Commission in 2007. Further details are available on the company’s website.
European Market Expansion of 365 Energy Gains Further Momentum
365 Energy has announced the installation of the first Coulomb ChargePoint® Networked Charging Stations in Dublin, Ireland. The charging stations were provided to Ireland’s Electric Supply Board (ESB) and recently went live in the Dublin city centre. The installation of these charging stations is only the beginning of Ireland’s nationwide e-mobility infrastructure initiative. The ESB is planning to install charging stations in homes, on-street and along motor-ways throughout Ireland so that electric cars can be powered at a wide range of accessible venues.
SuppreMol GmbH, a privately held biopharmaceutical company developing novel therapeutics for the treatment of autoimmune diseases, today announced the initiation of a Phase Ib/IIa clinical trial with its lead product SM101 in Idiopathic Thrombocytopenic Purpura (ITP) in Europe. For further details on the trial and the compound, please see the complete press release.
In a Phase Ia trial in 48 healthy volunteers started in April 2009, no SM101-associated adverse reactions have been observed. Detailed results of this study will be published soon.
Personalized medicine is regarded as the next big thing in healthcare, but so far business models to make money in this field are limited. One example is Hamburg-based Indivumed which specializes on the support of pharma companies and research institutions with cancer biospecimens and related data and services generated under highly standardized conditions. Another one, argues Steve Dickman of CBTadvisors in his recent Boston Biotech Watchblog, might be genetic counseling for prospective parents.
Steve judges potential success of businesses in the personalized medicine space according to four criteria, asking whether the concept is 1) actionable, 2) cost-effective, 3) based on validated science, and 4) clinically meaningful.
Going through this list he comes to the conclusion that the business model of California-based Counsyl looks promising. For $698 per couple the company is offering prospective parents a one-price panel of SNP-based tests for more than 100 genetic diseases so that a couple can learn whether its offspring is at risk for these conditions.
So while it is easy to tick the boxes on 2, 3, and 4, the questions is actionability: what are the options for treatment, preventive action, or behavior?
This is the field we predict will be hotly debated, at least in Europe. Once a risk is detected, the options on the table are: refrain from conceiving a child and opt for adoption, or choose abortion in case the child is affected by the condition the risk was predicted for, or go for in vitro fertilization followed by preimplantation genetic diagnosis.
While many may not like the idea because it evokes memories of eugenics, reality shows that many people do want to know what their genes and their options are. Anyone dare to place a ban on it?
